Status:
TERMINATED
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Lead Sponsor:
University Hospital, Saarland
Collaborating Sponsors:
University Medical Center Groningen
Pfizer
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.
Eligibility Criteria
Inclusion
- Persistent atrial fibrillation (AF), AF persistence for \> 7 days but \< 1 year
- Total AF history \< 2 years
- Written informed consent of the patient
- Age ≥18 years
- Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index \<1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse.
Exclusion
- Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks
- Myocardial infarction within the last 3 months
- Heart failure NYHA class III - IV
- Uncontrolled hypertension, defined as a systolic blood pressure \> 160 mm Hg and/or a diastolic blood pressure \> 95 mm Hg (anti-hypertensive treatment is allowed).
- Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics
- Instable angina pectoris
- Use of Digitalis
- Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)
- Contraindication or hypersensitivity to ß-blockers
- Open heart surgery within the last 3 months
- Pregnancy
- Acute and reversible illnesses
- Acute and chronic infection
- Alcohol or drug abuse or a severe progressive extracardiac disease
- Untreated manifest and latent hyper- or hypothyroidism or \< 3 months peripheral euthyroidism (normal fT3)
- Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)
- Patients with liver cirrhosis (Child-Pugh class C)
- Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon)
- Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)
- Serum potassium \> 5 mmol/l
- Patients unlikely to comply with the protocol
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00647192
Start Date
March 1 2008
End Date
February 1 2012
Last Update
February 10 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg/Saar, Germany, 66421
2
Rijksuniversiteit Groningen, Universitair Medisch Centrum
Groningen, Netherlands, NL-9700 RB